Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

Study on the Prevention of Atrial Fibrillation Recurrence After Ablation by Qidong Yixin Granule

Q: Who can participate in NCT07508618?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT07508618?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

Study on the Prevention of Atrial Fibrillation Recurrence After Ablation by Qidong Yixin Granule Based on Multicenter Clinical Trials and Omics Mechanisms

Study on the Prevention of Atrial Fibrillation Recurrence After Ablation by Qidong Yixin Granule (NCT07508618) is a Phase 4 interventional studying Persistent Atrial Fibrillation, sponsored by Sir Run Run Shaw Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

The goal of this clinical trial is to investigate the efficacy and safety of Qidong Yixin Granules in preventing recurrence in patients after radiofrequency catheter ablation for atrial fibrillation. The main question it aims to answer is: Can Qidong Yixin Granules reduce the recurrence rate of atrial fibrillation within 1 year in patients undergoing radiofrequency catheter ablation for atrial fibrillation? Participants will be randomly assigned, with a 50% chance of being allocated to either the study group or the control group. Regardless of which group a participant is assigned to, researchers will administer Qidong Yixin Granules or placebo within 48 hours after catheter ablation for atrial fibrillation. Group assignment is determined by computer-generated randomization, and no individual has the authority to interfere with the allocation result. If a participant is assigned to the study group, they will receive oral Qidong Yixin Granules after atrial fibrillation ablation: one sachet each time, three times daily, for a 12-month treatment course. If a participant is assigned to the control group, they will receive oral placebo matching Qidong Yixin Granules after atrial fibrillation ablation: one sachet each time, three times daily, for a 12-month treatment course. Regardless of the group assignment, all participants will attend outpatient follow-up at 1, 3, 6, 9, and 12 months postoperatively. Electrocardiography (ECG) and ambulatory electrocardiography (Holter monitoring) will be performed at 1, 3, 6, and 12 months after surgery. Transthoracic echocardiography will be conducted at 3 and 12 months postoperatively. Anticoagulation will be administered for at least 3 months after surgery, and subsequent anticoagulation strategies will be determined based on the CHA₂DS₂-VASc score.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 846 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - Age 18-80 years (inclusive); - Diagnosed with non-valvular persistent atrial fibrillation, having failed at least one antiarrhythmic drug treatment, and scheduled to undergo initial ablation; - Voluntarily participate in this study and sign an willing to sign a consent form form. If the subject is unable to read or sign the willing to sign a consent form form due to reasons such as lack of capacity, the willing to sign a consent form process must be completed and signed by their legal guardian. If the subject is unable to read the willing to sign a consent form form (e.g., illiterate subjects), the willing to sign a consent form process must be witnessed and signed by a witness. Who Should NOT Join This Trial: - Valvular atrial fibrillation or paroxysmal atrial fibrillation - NYHA functional class IV or LVEF \<40%, LA diameter \>55mm; - Moderate to severe left ventricular hypertrophy (wall thickness \>1.5cm); - Patients with acute coronary syndrome or requiring stent implantation - Patients with a history of cardiac surgery within the past 6 months or previous catheter ablation - Duration of atrial fibrillation ≥5 years; - Hyperthyroidism; - Patients with atrial fibrillation and cardiomyopathy; - Patients with bradyarrhythmia requiring pacemaker implantation - Known bleeding diathesis, presence of left atrial/left atrial appendage thrombus, or severe hemostasis and coagulation dysfunction - Severe hepatic or renal insufficiency ALT ≥3 × ULN or eGFR \<45 ml/min/1.73 m²; - Patients allergic to the components of the study drug; - Patients who are currently participating or have participated in other interventional clinical studies within the past 3 months. - Pregnant or lactating women, or those with an expected lifespan of \<12 months; - Other vulnerable groups, excluding the elderly/illiterate individuals, including those with mental illnesses, cognitive impairments, critically ill patients, etc ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Age 18-80 years (inclusive); * Diagnosed with non-valvular persistent atrial fibrillation, having failed at least one antiarrhythmic drug treatment, and scheduled to undergo initial ablation; * Voluntarily participate in this study and sign an informed consent form. If the subject is unable to read or sign the informed consent form due to reasons such as lack of capacity, the informed consent process must be completed and signed by their legal guardian. If the subject is unable to read the informed consent form (e.g., illiterate subjects), the informed consent process must be witnessed and signed by a witness. Exclusion Criteria: * Valvular atrial fibrillation or paroxysmal atrial fibrillation * NYHA functional class IV or LVEF \<40%, LA diameter \>55mm; * Moderate to severe left ventricular hypertrophy (wall thickness \>1.5cm); * Patients with acute coronary syndrome or requiring stent implantation * Patients with a history of cardiac surgery within the past 6 months or previous catheter ablation * Duration of atrial fibrillation ≥5 years; * Hyperthyroidism; * Patients with atrial fibrillation and cardiomyopathy; * Patients with bradyarrhythmia requiring pacemaker implantation * Known bleeding diathesis, presence of left atrial/left atrial appendage thrombus, or severe hemostasis and coagulation dysfunction * Severe hepatic or renal insufficiency ALT ≥3 × ULN or eGFR \<45 ml/min/1.73 m²; * Patients allergic to the components of the study drug; * Patients who are currently participating or have participated in other interventional clinical studies within the past 3 months. * Pregnant or lactating women, or those with an expected lifespan of \<12 months; * Other vulnerable groups, excluding the elderly/illiterate individuals, including those with mental illnesses, cognitive impairments, critically ill patients, etc * Any other reasons deemed by the investigator as unsuitable for the patient's participation in this study

Treatments Being Tested

DRUG

Qi Dong Yi Xin Granules

If a participant is assigned to the study group, they will receive oral Qidong Yixin Granules after atrial fibrillation ablation: one sachet each time, three times daily, for a 12-month treatment course.

DRUG

Placebo

If a participant is assigned to the control group, they will receive oral placebo matching Qidong Yixin Granules after atrial fibrillation ablation: one sachet each time, three times daily, for a 12-month treatment course.

Locations (5)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, China

Deqing People'S Hospital

Huzhou, China

Ningbo No.2 Hospital

Ningbo, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07508618), the sponsor (Sir Run Run Shaw Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07508618 clinical trial studying?

Who can participate in NCT07508618?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07508618?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07508618. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07508618. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.